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					Scottish Hyperacute stroke Activity
Register and Evaluation (SHARE)

          Peter Langhorne
        University of Glasgow
 What’s in a name?
S – Scottish
H - Hyperacute
A – Assessment and
M - Management
E - Evaluation
 What’s in a name?
S – Scottish
H - Hyperacute
I - Investigation and
T - Treatment
E - Evaluation
 What’s in a name?
S – Scottish
H – Hyperacute stroke
A – Activity
R – Register and
E - Evaluation
              Stroke in Scotland
• Over 10,000 people have a
  new stroke each year
• 70,000 Scots living with
  consequences of a stroke
• Average lifetime cost of
  stroke £45,000
• Good progress in
  developing services
• SSCA has help drive up
  standards
Thrombolysis in acute stroke




  Before            After
In 2002, European Union regulatory authority
approved rt-PA for stroke CONDITIONALLY

                            • Within 3 hours of an
                              ischaemic stroke
                            • Age 18-80
                            • In high quality stroke centres with
                              stroke units with certain monitoring
                              requirements
                     Time is Brain
Impact of thrombolysis
Number making full recovery per 100 treated


30
             Benefit
20

10

0
     0        2           4       6
                           Time (hours)

                                              Saver, Stroke 2006
Haemorrhage into an infarct
                     Time is Brain
Impact of thrombolysis
Number making full recovery per 100 treated


30
             Benefit
20

10
                                   Harm

0
     0        2           4       6
                           Time (hours)

                                              Saver, Stroke 2006
             Inclusion criteria
• Clinical symptoms and signs of definite acute
  stroke
• Clear time of onset
• Presentation within 3 hrs of acute onset
• Haemorrhage excluded by CT scan
• Age 18 - 80 years old
• NIHSS less than 25
• Consent to treat (every effort must be made to
  contact next of kin)
                                   Exclusion criteria
•   Rapidly improving or minor stroke symptoms               •   Ulcerative GI disease last 3 months, oesophageal
•   Stroke or serious head injury 3 months                       varices, arterial-aneurysm, arterial/venous
•   Major surgery, obstetrical delivery, external heart          malformation.
    massage last 14 days,                                    •   Severe liver disease including cirrhosis, acute
•   Seizure at onset of stroke                                   hepatitis
                                                             •   Neoplasm with increased bleeding risk
•   Prior stroke and concomitant diabetes
                                                             •   Large hypodensity on CT scan (use ASPECTS*
•   Severe haemorrhage last 21/7                                 scoring if time permits; otherwise use the 1/3 of
•   Increase bleeding risk                                       MCA territory rule)
•   History of central nervous damage (neoplasm,             •   Symptoms suggestive of SAH (even if CT is
    haemorrhage, aneurysm, spinal or intracranial surgery or     normal)
    haemorrhagic retinopathy)                                •   *Blood pressure above 185 mmHg systolic or 110
                                                                 mmHg diastolic
•   Symptoms suggestive of SAH (even if CT is normal)
                                                             •   Known clotting disorder
•   *Blood pressure above 185 mmHg systolic or 110           •   Patient on heparin or warfarin
    mmHg diastolic
                                                             •   Suspected iron deficient anaemia or
•   Known clotting disorder                                      thrombocytopenia
•   Patient on heparin or warfarin                           •   Suspected hypoglycaemia or hyper glycaemia >3
•   Suspected iron deficient anaemia or thrombocytopenia         mmol/l > 22 mmol/l
•   Suspected hypoglycaemia or hyper glycaemia >3            •   Bacterial endocarditis, pericarditis
    mmol/l > 22 mmol/l                                       •   Acute pancreatitis
•   Bacterial endocarditis, pericarditis                     •   Premorbid dependency
•   Acute pancreatitis                                       •   Ulcerative GI disease last 3 months, oesophageal
                                                                 varices, arterial-aneurysm, arterial/venous
•   Premorbid dependency                                         malformation.
              Low density
              loss of grey/white definition
              loss of insula
              loss of basal ganglia            Hyperdense artery




                                     Swelling
                                   loss of sulci
                             effacement of ventricles
Farrall, Kane, Wardlaw
               Conditions
• Acute stroke unit
• Under the care of stroke physician or
  neurologist
• Monitored bed
• Nurses trained in thrombolysis & acute
  skills
• Protocols & guidelines for care
• Access to immediate imaging (24hrs)
CT head scanning availability
Hyperacute stroke specialist teams




               
                  
                
               
    Patient has Video Consultation with the
consultant following viewing of CT brain image
                       -
Network of acute sites (with CT scanning) and
             stroke specialists




                    
                       
                     
                    
                           Use of rt-PA for acute ischaemic stroke ‘within
                           licence’ in Europe (SITS-MOST registry 2007)
                                     250                          Finland
rt-PA for stroke per million pop'n


                                                                  Sweden
                                                                  Austria
                                                                  Norway
                                                                  Czech Republic
                                     200                          Slovenia
                                                                  Belgium
                                                                  Denmark
                                                                  Spain
                                     150                          Iceland
                                                                  Germany
                                                                  Portugal
                                                                  Italy
                                                                  Slovakia
                                     100                          Australia
                                                                  Netherlands
                                                                  United Kingdom
                                                                  Lithuania
                                                                  Poland
                                     50                           France
                                                                  Greece
                                                                  Croatia
                                                                  Hungary
                                                                  Russia
                                      0
                                                            SITS-MOST 29/1/2007
                                  SITS Register
                                                           •   DeathTreatment file nameSITS-MOST patientAgeGenderDate
•   Section                                                    of deathPrimary cause of deathCause of death reasonable
                                                               related to Actilyse treatmentAdd. info. related to deathSerious
•   Data itemBaselineTreatment file namePostcodeCHI            AD report formNIH stroke scale - BeforeNIH done – before
    numberAgeGenderSITS-MOST patientDate/time                  treatmentIf NIH done – total scoreSystolic BPDiastolic BPNIH
    stroke onsetDate/time arrival 1st hospitalDate/time        items 1-11NIH total (calculated)NIH stroke scale – At 2hNIH
    arrival Rx hospitalDate/time brain imaging                 done – at 2hSystolic BPDiastolic BPNIH items 1-11NIH total
                                                               (calculated)NIH stroke scale – At 24hNIH done – at
    examDate/time brain imaging reportDate/time of rt-         24hSystolic BPDiastolic BPNIH items 1-11NIH total
    PA treatmentRankin before                                  (calculated)NIH stroke scale – At 7dNIH done – at 7dSystolic
    strokeHypertensionDiabetesHyperlipidaemiaCurrent           BPDiastolic BPNIH items 1-11NIH total
    smokerPrevious smokerPrevious diagnosis of                 (calculated)ImagingCT doneCT date/timeCT current infarctCT
    strokeAtrial fib (incl. Paroxysmal)Congestive heart        dense artery signCTA occlusion (optional)CT perfusion deficit
                                                               (optional)CT perfusion deficit volume optCT infarct volume
    failureNumber of risk factorsAspirin at stroke             (optional)CT perfusion/infarct mismatch (optional)CT local
    onsetDipyridamole at stroke onsetClopidogrel at            haemorrhageCT remote haemorrhageCT volume PH2CT
    stroke onsetOther antiplatelet at stroke                   cerebral oedemaMR doneMR date/timeMR current infarctMR
    onsetAnticoagulants, high doseAnticoagulants, low          artery occlusionMR perfusion deficit (optional)MR diffusion
    doseAnticoagulants, oralAntihypertensive at stroke         volume (optional)MR perfusion/infarct mismatch (optional)MR
                                                               local haemorrhageMR remote haemorrhageMR volume
    onsetAntihypertensive oralGlucose before                   PH2MR cerebral oedemaBrain Imaging result [d]TCD
    treatmentTotal serum cholesterol level within 24h of       occlusionTCD date/timeTreatmentTreatment file nameSITS-
    stroke onsetCurrently partic. In stroke RCTMethod          MOST patientAgeGenderHas patient received treatment with
    of consultation [a]Brain imaging review                    ActilyseDose mgEstimated weight (kilos)Measured weight
    [b]ADRCause of ADR is reasonable related to                (kilos)Reason why no treatment was given [e]Full dose given
                                                               (0.9mg/kg)Reason why full dose was not given24hTreatment
    Actilyse treatmentType of ADRDate SADR faxed to            file nameSITS-MOST patientAgeGenderGlobal outcome 24h
    BIIntensity of ADRDate/time of onset of                    after start of rt-PA treatment [f]DischargeTreatment file
    ADRSpecify reaction [c]Treatment file nameSITS-            nameSITS-MOST patientAgeGenderAspirin since
    MOST patientAgeGenderCause of ADR is                       admissionDipyridamol since admissionClopidogrel since
    reasonable related to Actilyse treatmentType of            admissionOther antiplatelet since admissionAnticoagulants,
                                                               high doseAnticoagulants, low doseAnticoagulants,
    ADRDate SADR faxed to BIIntensity of                       oralAntihypertensive, ivAntihypertensive, oralI-national class
    ADRCriteria of serious ADRDate/time of onset of            of diseases(ICD)Repeat brain imaging done [g]Repeat brain
    ADRSpecify reactionSerious AD report form                  imaging result [h]Global outcome on discharge /7dGlobal
                                                               outcome on discharge /7d [i] ?Total serum cholesterol level at 7
                                                               days of stroke onset, mg/dl3 month follow upTreatment file
                                                               nameSITS-MOST patientAgeGenderRankin 3m months (+/- 10
                                                               days)
              SHARE project
Prospective part            Retrospective part
• Basic common dataset in   • Jan 2008 – present
  SSCA                      • Multiple local audits
• Numbers treated           • Compile basic common
• Contraindications           dataset
• Time to treatment         • Same data as SSCA
• Complications             • Same outcomes and
• Outcomes                    analysis
• Equity/service issues     • Centralised resource
              SHARE project
Prospective part            Retrospective part
• Basic common dataset in   • Jan 2008 – present
  SSCA                      • Multiple local audits
• Numbers treated           • Compile basic common
• Contraindications           dataset
• Time to treatment         • Same data as SSCA
• Complications             • Same outcomes and
• Outcomes                    analysis
• Equity/service issues     • Centralised resource
Section            Data item                                       Details
Patient details    Date/time arrival at treating hospital
                   Date/time brain imaging exam
                   Date/time of rt-PA treatment
                   If not given, reason why no treatment was       Too late, medical contraindication,
                   given                                           radiological contraindication, other.
Process            Method of consultant consultation               Face-to-face, videoconference, telephone,
                                                                   other
                   Brain imaging review                            Stroke consultant, radiologist, other
                   Brain Imaging result
NIH stroke scale   NIH done – before treatment
                   If NIH done – total score                       NIHSS
Discharge
Repeat imaging     Repeat brain imaging done                       yes/ no
                   Date of repeat imaging
                   Repeat brain imaging result                     normal, infarct, haemorrhage, other
Adverse reaction   ADR occurred - reasonably related to Actilyse   Anaphylaxis, symptomatic intracranial
(ADR)              treatment                                       haemorrhage, other haemorrhage, other
                   Date of ADR
Outcome            Function                                        Rankin score
3 Month            Function                                        Rankin score (optional?)
  The promise and challenge of
thrombolysis for ischaemic stroke
• Promising treatment for a minority of stroke
  patients
• National and international guidelines NICE
  technology appraisal
• Features in Scottish and English stroke strategies
• Challenge to deliver in practical and equitable
  manner
• Need to monitor developments in Scotland